受试者招募 现有一项“APG-2575单药治疗复发或难治性慢性淋巴细胞白血病/小淋巴细胞淋巴瘤的有效性和安全性的单臂关键注册II 期临床研究”正在开展并招募受试者。 入组条件 本研究已获得国家药品监督管理总局批准并通过各参与研究中心伦理委员会的审核，如果您符合以下条件，将有机会参加本项临床研究： ● 复发或难治慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL） ● BTK抑制剂和免疫化疗均难治、复发、或不耐受；或：一线BTK抑制剂治疗失败且不适合免疫化疗 ● 年龄≥ 18岁，男性或非妊娠非哺乳期女性 ● 能够理解并自愿签署书面知情同意书 ● 自愿参加并能完成研究程序和随访检查 还需满足其他研究要求，如果您同意参加研究，研究医生将对您是否满足其他要求进行评估。 不需要为研究药物和本研究要求的检测、检查支付费用。 如果您满足以上条件且有意参加或有兴趣进一步了解该项研究更多信息，请联系：18907327297（马盼盼）

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that it has released results from a Phase I study of the company’s novel Bcl-2-selective inhibitor lisaftoclax (APG-2575) in Chinese patients with relapsed/refractory non-Hodgkin lymphoma (r/r NHL) at the 2022 European Hematology Association Hybrid Congress (EHA 2022). The EHA Congress is the largest gathering of the hematology field in Europe. It showcases the most cutting-edge research and state-of-the-art innovative therapies, attracting over 10,000 clinical experts and researchers from more than 100 countries every year. Lisaftoclax Bcl-2-selective inhibitor  Lisaftoclax is a novel, orally administere

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that it will release the latest results from a Phase I study of lisaftoclax (APG-2575), the company’s novel Bcl-2 selective inhibitor, in Chinese patients with relapsed/refractory non-Hodgkin lymphomas (r/r NHLs) at the 2022 European Hematology Association Hybrid Congress (EHA 2022), making it the company’s first appearance at the EHA Congress. The EHA Congress is the largest gathering of the hematology field in Europe. It showcases most cutting-edge research and state-of-the-art innovative therapies, attracting over 10,000 clinical experts and researchers from over 100 countries every year. This year, the EHA

曾有一位教授说，“如果一定要生肿瘤，情愿是慢粒。”慢粒白血病，慢性白血病中最常见的一种类型，占成人白血病的15%。随着第一代靶向治疗药物的出现，慢粒白血病被称为“最幸运的白血病”，10年生存率高达85%-90%，实现和常人一样生存。数据之下，个体与疾病的搏击、新药的诞生、医生的努力、家庭的迷茫与坚持交织在一起，呈现着数据难以承载的生命张力。 9月22日是国际慢粒日，听一名85后慢粒患者说确诊故事，七年时间仿佛是在“不幸”与“幸运”之间折返跑。对这个小家庭而言，生死面前一切反而变得纯粹，就是要奋力“定格幸运”。 【本文转载自文汇报】 图源：图虫 01 哈尔滨的夏，一家人的心情降至冰点 没察觉到什么身体异样，于洋是在退伍归来工作七八年后，被确诊为慢粒的。 “当时，是单位例行体检，发现我的白细胞增高很多，体检的医院让我去复查，正常人的白细胞指标在4-10之间，我当时是20多，翻倍了。”于洋记得前往医院复查后，白细胞指标依旧很高，医生让住院接受骨穿等一系列检查。等一系列检查结果出来，他确诊了——是慢粒。 这是2013年的夏天，于洋28岁，拿着诊断报告，虽是哈尔滨的夏天，一家人的心情降到了冰点。 “以前没听说过这病，非常恐惧、迷茫。”出院后的于洋开始服用羟基脲维持治疗，“吃了一段羟基脲后，感觉血常规都正常了，就没怎么吃药了。” 大约一年后，于洋发现身体上的异样，总感觉没有力气，“当时也不知道是脾脏肿大，还当胃治，后来到了血液科，医生说是脾脏肿大，然后一查白细胞已经300多了。”于洋原以为吃羟基脲可以把血常规指标调整好，就没事了，直到脾脏出现问题、白细胞“严重超标”，他才知道这是不够的，“正规治疗”这才起步。 那是2014年的七八月，于洋住院了，继续服用羟基脲，并开始吃国产仿制靶向药。 于洋是不幸的，年纪轻轻确诊白血病。中国慢粒患者发病较西方更为年轻化，流行病学调查显示，中国慢粒患者的

Ascentage Pharma (6855.HK) today announced that updated results from seven studies involving the company’s five novel drug candidates will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The company will present clinical trials involving the third-generation tyrosine kinase inhibitor (TKI) olverembatinib (HQP1351); as well as the following investigational agents: (1) Bcl-2 inhibitor lisaftoclax (APG-2575); (2) MDM-p53 inhibitor alrizomadlin (APG-115); (3) ALK inhibitor APG-2449; and (4) dual Bcl-2/Bcl-xL inhibitor pelcitoclax (APG-1252). The ASCO Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world’s most influential and prominent scientific gathering of the cl

Ascentage Pharma (6855.HK) announced today that lisaftoclax (APG-2575), a novel Bcl-2 inhibitor and one of the company’s core assets, has been cleared by the US Food and Drug Administration (FDA) to enter a global registrational Phase III study for treatment of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who were BTKi previously treated . This clearance marks a major step-forward in the global development of lisaftoclax and another important milestone following the approval by the Center for Drug Evaluation (CDE) in China for the registrational Phase II study of lisaftoclax (APG-2575) in patients with relapsed/refractory CLL/SLL (R/R CLL/SLL) in December 2021, as it could potentially pave the way for lisaftoclax to become the second Bcl-2 inhibitor

Ascentage Pharma (6855.HK) today announced that the Phase Ib study of Ascentage Pharma’s novel drug candidate, olverembatinib (HQP1351), for the treatment of patients with refractory chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) has been approved by Health Canada, making it Ascentage Pharma’s first clinical study in the country. This open-label, multicenter, randomized, global Phase Ib study is designed to evaluate the safety, efficacy, pharmacokinetics (PK) and determine the recommended Phase II dose (RP2D) of olverembatinib in patients with CML in chronic-phase (CP), accelerated-phase (AP), or blast-phase (BP) or with Ph+ ALL, who are resistant or intolerant to at least two tyrosine kinase inhibitors (TKIs). CML is a hematologic

Ascentage Pharma (6855.HK) today announced that it has released the updated results from a Phase II study of the MDM2-p53 inhibitor alrizomadlin (APG-115) plus pembrolizumab in adults and children with various solid tumors in a Poster Discussion session at the 58th American Society of Clinical Oncology (ASCO) Annual Meeting. Entering the fifth consecutive year in which its abstracts were selected for presentations by the ASCO Annual Meeting, Ascentage Pharma showcased results from multiple clinical trials of its five drug candidates, including the much-anticipated data of alrizomadlin plus pembrolizumab, updated from the data at last year’s oral presentation at the ASCO Annual Meeting. The updated results further validate the combination therapy’s efficacy in patients with immuno-oncologic

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that its Chairman and CEO, Dr. Dajun Yang, has accepted an invitation to speak at the 41st Annual J.P. Morgan Healthcare Conference, at 08:30 AM, January 11, 2023, Pacific Time (00:30 AM, January 12, 2023, Beijing Time), to provide an update on Ascentage Pharma’s progress with its proprietary innovation and global R&D. The annual J.P. Morgan Healthcare Conference is the largest and most informative event for the global pharmaceutical industry and the investment community. The 41st Conference will take place in San Francisco, California, the United States, on January 9-12. Time: January 11, 08:30–08:55 AM,

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced its participation in and presentation at the 40th Annual J.P. Morgan Healthcare Conference. Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, will present at the conference on January 10th, 2022 at 9:00-9:25 AM ET (10:00-10:25 PM China Standard Time). The annual J.P. Morgan Healthcare Conference is the largest and most informative healthcare investment symposium in the industry. The 40th Conference will take place virtually from January 10th through January 13th, 2022, ET. The webcast of the presentation can be listened at the link below. https://jpmorgan.metameetings.net/events/healthcare22/sessions/403

亚盛医药（6855.HK）与信达生物制药集团（1801.HK）共同宣布，原创1类新药奥雷巴替尼片（商品名：耐立克®）已成功纳入《国家基本医疗保险、工伤保险和生育保险药品目录（2022年）》（以下简称国家医保目录），医保支付范围为：“限T315I突变的慢性髓细胞白血病（也称慢性粒细胞白血病，简称慢粒）慢性期或加速期的成年患者。”新版医保目录将于2023年3月1日起正式生效。 耐立克®是亚盛医药原创1类新药，为中国首个且唯一获批上市的第三代BCR-ABL抑制剂，也是伴有T315I突变的慢粒唯一治疗药物，获“十二五”、“十三五”国家“重大新药创制”专项支持，具有全球同类最佳（Best-in-class）潜力。该品种于2021年11月获批在中国上市，耐立克®在中国的商业化推广由亚盛医药与信达生物共同负责。 此次耐立克®成功纳入国家医保目录，再次证明其是满足患者急需、填补临床空白、疗效和安全性俱优的创新药物。进入国家医保目录将进一步提升耐立克®的患者可及性和可负担性，让更多慢粒患者有药可用、用得起药、用得上药，从而延续生命精彩，并为家庭和社会做出贡献。 慢粒是骨髓造血干细胞克隆性增殖形成的恶性肿瘤，是慢性白血病中最常见的一种类型，占成人白血病的15%[1]-[2]。现有的流行病学调查数据显示，中国慢粒患者的中位发病年龄为45-50岁，比西方患者年轻近20岁[3]，正是家庭中流砥柱的年纪。 随着靶向BCR-ABL的酪氨酸激酶抑制剂（TKI）药物上市，针对慢粒的治疗方式得以革新，慢粒患者可通过规范服药，获得长期的生存获益，甚至回归工作与生活。但获得性耐药一直是慢粒治疗的主要挑战。其中，伴有T315I突变的慢粒患者对目前所有一代、二代BCR-ABL抑制剂均耐药，长期困扰患者治疗。耐立克®作为中国首个和唯一获批上市的第三代BCR-ABL抑制剂，也是伴有T315I突变的慢粒唯一治疗药物，填补了